Life Sciences Horizons Brochure 2025 - Flipbook - Page 94
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2025 Horizons Life Sciences and Health Care
How medical device companies should navigate the evolving AI regulatory
landscape (continued)
What steps can companies take now?
Foster industry collaboration and advocacy
Given the lack of global conformity for AI oversight, medical
device companies can voluntarily adopt best practices in a
number of areas:
Medical device companies should engage with industry groups,
regulatory bodies, and AI standardization organizations to help
shape policies and best practices. Participating in public-private
initiatives and advocating for regulatory clarity will enable
companies to influence the emerging AI framework and ensure
practical, innovation-friendly regulations.
AI governance
A bedrock of AI development is solid governance processes.
To do so, companies can:
Establish AI ethics committees to oversee development and
deployment;
Implement robust documentation and audit trails for AI
decision-making;
Adopt risk management frameworks similar to those outlined
in ISO14971 and the EU AI Act; and
Ensure compliance with existing regulations such as HIPAA for
data privacy and the FDA’s software as a medical device (SaMD)
guidelines.
Transparency and explainability
Regulators and health care professionals increasingly demand
AI systems that are interpretable and accountable. Companies
should prioritize explainability in AI models, ensuring
clinicians and regulators understand how decisions are made.
Implementing clear documentation, model validation, and
postmarket performance monitoring will help build trust and
regulatory readiness.
Future-proof AI strategies with adaptive compliance
With AI regulation still evolving, companies should build
flexibility into their compliance strategies. Adopting an adaptive
compliance model — where AI systems can be updated in
response to regulatory changes — will be critical in ensuring
long-term viability and global market access.
While the EU AI Act provides a clear regulatory direction,
the U.S. is still in the process of defining its AI governance
framework. In this transitional period, medical device
companies must take proactive steps by aligning with existing
international standards, strengthening internal AI governance,
and engaging with policymakers. By doing so, they can navigate
regulatory uncertainty while maintaining compliance, fostering
innovation, and ensuring the safety and efficacy of AI-powered
medical devices.
Cybil Roehrenbeck
Partner
Washington, D.C.
Jodi Scott
Partner
Denver
